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Last Updated: December 22, 2024

GEMMILY Drug Patent Profile


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Which patents cover Gemmily, and what generic alternatives are available?

Gemmily is a drug marketed by Xiromed and is included in one NDA.

The generic ingredient in GEMMILY is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

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US Patents and Regulatory Information for GEMMILY

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Xiromed GEMMILY ethinyl estradiol; norethindrone acetate CAPSULE;ORAL 213317-001 Nov 9, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

GEMMILY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: GEMMILY

Introduction

Gemmily, a combination oral contraceptive, is a prescription medication containing norethindrone and ethinyl estradiol, along with ferrous fumarate in the placebo capsules. Understanding its market dynamics and financial trajectory involves examining its usage, competition, pricing, and the broader pharmaceutical market context.

Market Context

The pharmaceutical market, particularly for contraceptives, is highly competitive and regulated. Gemmily operates within a segment that is subject to strict medical guidelines and patient preferences.

Competitive Landscape

Gemmily competes with other combination oral contraceptives (COCs) available in the market. The competitive landscape is characterized by a multitude of brands and generics, each with their own formulation and pricing strategy. Major pharmaceutical companies often dominate this space, but niche players like the manufacturer of Gemmily also have a significant presence[4].

Patient Population

The target population for Gemmily includes women of reproductive age seeking oral contraception. The demand for such products is steady, driven by the need for effective and convenient birth control methods.

Pricing and Cost

List Price and Discounts

The cost for Gemmily can vary depending on the pharmacy and location. On average, a supply of 84 capsules (a 3-month supply) costs around $560. This pricing is competitive with other COCs in the market[5].

Insurance Coverage

Gemmily, like many other prescription drugs, may not be covered by all Medicare prescription drug plans (Part D). Patients often need to verify coverage with their specific plan, which can affect the financial trajectory of the drug[2].

Financial Trajectory

Revenue Generation

The revenue generated by Gemmily is influenced by its prescription volume, pricing, and insurance coverage. Given its niche position in the market, Gemmily's revenue is likely to be stable but may not see the exponential growth observed in other pharmaceutical segments, such as the obesity treatment market[3].

Market Size and Growth

While the market for oral contraceptives is substantial, it is not as expansive or rapidly growing as some other pharmaceutical markets. For example, the market for weight loss drugs, particularly GLP-1s, is projected to reach $100 billion to $150 billion annually in the U.S. alone by 2030. In contrast, the contraceptive market, while significant, does not exhibit such dramatic growth projections[3].

Regulatory and Clinical Considerations

Contraindications and Warnings

Gemmily has several contraindications, including high risk of thrombotic diseases, liver tumors, undiagnosed abnormal uterine bleeding, and pregnancy. These contraindications can impact its market dynamics by limiting its user base and requiring careful patient selection[1][4].

Clinical Trials and Efficacy

Gemmily's efficacy is supported by clinical trials that demonstrate its ability to suppress gonadotropins, inhibit ovulation, and alter cervical mucus and endometrium to prevent pregnancy. However, its clinical trial data may not be as extensive or groundbreaking as those for newer, high-growth pharmaceuticals[4].

Patient Counseling and Compliance

Administration and Compliance

Patient compliance is crucial for the effectiveness of Gemmily. The drug must be taken at the same time every day, and patients are advised to use backup contraception during the first seven days of administration. Non-compliance can lead to reduced efficacy and increased risk of adverse reactions[1][4].

Adverse Reactions and Safety Profile

Common Adverse Reactions

Gemmily is associated with several common adverse reactions, including headache, vaginal candidiasis, nausea, menstrual cramps, and breast tenderness. These reactions can affect patient satisfaction and long-term use of the drug[1][4].

Conclusion

Gemmily operates in a stable but competitive market for oral contraceptives. Its financial trajectory is influenced by its pricing, insurance coverage, and regulatory environment. While it is not expected to see the rapid growth observed in other pharmaceutical segments, it remains a viable option for women seeking effective birth control.

Key Takeaways

  • Stable Market: Gemmily is part of a stable market for oral contraceptives.
  • Pricing: The drug is priced competitively, with a 3-month supply costing around $560.
  • Insurance Coverage: Coverage varies by insurance plan, affecting patient access.
  • Regulatory Considerations: Contraindications and warnings limit its user base.
  • Clinical Efficacy: Supported by clinical trials demonstrating its contraceptive efficacy.
  • Patient Compliance: Critical for effectiveness, with specific administration guidelines.

FAQs

Q: What are the active ingredients in Gemmily?

A: Gemmily contains norethindrone acetate (1 mg) and ethinyl estradiol (20 mcg) in the active capsules, along with ferrous fumarate (75 mg) in the placebo capsules[1][4].

Q: How is Gemmily administered?

A: Gemmily is taken once daily for 28 days, with 24 active capsules followed by 4 placebo capsules containing ferrous fumarate[1][4].

Q: What are the common adverse reactions associated with Gemmily?

A: Common adverse reactions include headache, vaginal candidiasis, nausea, menstrual cramps, and breast tenderness[1][4].

Q: Is Gemmily covered by Medicare?

A: Generally, Medicare prescription drug plans (Part D) do not cover Gemmily. Patients should verify coverage with their specific plan[2].

Q: What are the contraindications for using Gemmily?

A: Contraindications include high risk of thrombotic diseases, liver tumors, undiagnosed abnormal uterine bleeding, pregnancy, and certain drug interactions[1][4].

Sources

  1. GEMMILY Prescription & Dosage Information - eMPR.com
  2. Gemmily Medicare Coverage and Co-Pay Details - GoodRx
  3. A Multi-Billion-Dollar Drug Market - Baron Funds
  4. Gemmily: Package Insert / Prescribing Information - Drugs.com
  5. Gemmily Prices, Coupons, Copay Cards & Patient Assistance - Drugs.com

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